Quality assurance manager - united kingdom, loughborough, leicestershire
this employer is a cutting edge translational technology company making precision medicine a reality. they bring clarity to drug discovery around the world by helping biopharmaceutical companies solve some of today's most pressing challenges in oncology drug discovery.
they are looking for an enthusiastic qa manager to join the oncology in vivo team based in loughborough uk. this is an opportunity to work with highly motivated colleagues in a science-oriented, creative and dynamic environment. the qa manager is both primary point of contact and subject matter expert of the quality department.
the work is full-time and performed on location.
key responsibilities:
- collate and share information/data across the facility as appropriate through reports and follow up on identified improvement opportunities
- provide focus for the quality management system and work closely with all departments and functions to promote processes that ensure consistency, continuous improvement and compliance with quality and business requirements
- act as facility admin of the global eqms platform (veeva vault), with supervision and approval of workflows for investigations, root cause analysis, capa implementations and effectiveness checks
- perform internal audits as required according to facility and global plans
- review operational processes to ensure whether they align and comply with current regulations and policies
- prepare, host and respond to findings for external audits, and ensure that the facility retains its iso 9001:2015 certificate
- measure, monitor and report quality performance against agreed kpis
- formally and unambiguously present results, findings and overviews during facility management and quality meetings
- partner closely with internal stakeholders to maintain and comply with current h&s regulations
- actively contribute to the success of the overall qa team and the facility
- actively participate and/or drive eu/global qms improvements
what is on offer?
- 25 days annual leave entitlement, plus bank holidays
- professional development opportunities
- free on-site parking
what can you bring to the team?
- commercial awareness by understanding the importance of meeting client requirements, prompt follow-ups and meeting deadlines
- ability to work as part of a team to collaborate across local departments and global facilities
- analytical skills to make competent decisions based on review of research data
- problem solving and process improvement skills
- bachelor's degree in a scientific/technical field (e.g. biology, biochemistry, pharmaceuticals or engineering)
- minimum 5 years of experience in the life sciences industry (cro preferred)
- research laboratory understanding (i.e. in vivo & in vitro testing)
- eqms practiced (e.g. veeva vault, mastercontrol, trackwise)
- quality tools and methodologies proficient (e.g. iso 9001, pdca, fmea, 8d,5 why, rca, smart, six sigma
to join the team, apply today! or to hear more, apply now!
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